tbuckley/cabot-search huggingface dataset:
Racial/ethnic disparities in surgery access and outcome among non-metastatic HCC with an emphasis on Asian Americans.
Authors: Qian Wang, Virginia Corbett, Yaning Zhang, Changchuan Jiang, Paolo Boffetta, Myron E. Schwartz, Max W. Sung
Journal: Journal of Clinical Oncology (2022)

145 Background: Hepatocellular carcinoma (HCC) has the highest incidence and mortality in Asia. Though the incidence in the US has been decreasing, Asian Americans (AA) continues to face a significant burden from HCC. We aim to examine disparities in patients with non-metastatic HCC in receiving surgery and outcome, with an emphasis on AA ethnic subgroups. Methods: Patients diagnosed with localized or regional HCC were extracted from SEER 17 (1989-2019). Race was categorized into non-Hispanic White (NHW), non-Hispanic Black (NHB), Hispanic, Alaska Indian/American Native (AI/AN) and 12 AA subgroups. Multivariate logistic regression and Cox regression models were used to calculate the odds of receiving surgery and overall mortality, respectively. Results: Among the total of 71,552 patients with non-metastatic HCC (Table), after accounting for multiple comparison, Chinese and Japanese were significantly more likely to receive surgery while NHB, Hispanics, AI/AN, and Laotians were less likely to receive surgery compared to NHWs. Among those who received surgery, Chinese, Korean and other APIs had improved survival while NHB and Samoan had significantly increased overall mortality than NHWs. Conclusions: Although prior studies have combined AAs into a single group, considerable heterogeneity exists amongst AA ethnic subgroups. Further studies are needed to evaluate if socioeconomic status, cultural background, health behaviors, tumor biology, and health care access may underline these disparities and to help identify potential inventions to improve outcomes in this growing but heterogenous population.[Table: see text]
Number needed to harm (NNH) in patients with non-metastatic, castration-resistant prostate cancer (nmCRPC): A final analysis from the darolutamide (D), enzalutamide (E), and apalutamide (A) clinical trials.
Authors: Daniel J. George, A. Reginald Waldeck, Helen Guo, Alexander J. Upton
Journal: Journal of Clinical Oncology (2022)

326 Background: Second generation androgen receptor inhibitors (ARI) D, A and E, approved for the treatment of nmCRPC, offer benefit in overall survival (OS) and metastasis-free survival (MFS), but do so with different risk-benefit profiles. Contextualizing risks of adverse events (AEs), or harm to patients, can be challenging. NNH is a trial-based measure that evaluates the number of patients who need to receive treatment before a harmful outcome occurs with the intervention, compared to the control. Thus, a higher NNH reflects a lower incremental likelihood of harm. This study is an update to a previous NNH analysis, utilizing final data from the ARI randomized controlled trials (RCTs). Methods: MEDLINE and EMBASE were searched for relevant RCTs. AEs occurring in ≥5% of either RCT arm were extracted from the final ARAMIS (D), SPARTAN (A) and PROSPER (E) publications. NNH by AE (all grade, grade 3 &amp; 4) were calculated over the duration of each RCT based on reported rates, using the inverse of the absolute risk increase [1 / (experimental AE rate - control AE rate)]. An exploratory analysis considered the application of results to a US population, assuming trial-based AE rates to be representative of real-world rates. Results: Results show a trend of higher (i.e., favorable) NNH for AEs for D in ARAMIS across all grade and grade 3-4 AEs (Table), indicating a lower likelihood of incremental harm across AEs including fatigue, falls, hypertension and fracture for D versus A and E. Focusing on fatigue, fall and fractures, and selecting treatment with the highest (D) and lowest (A or E) NNH for an estimated 24,000 US high risk nmCRPC patients annually, treatment with D would translate to 4,073 fewer all-grade fatigue events, 2,928 fewer falls, and 2,383 fewer fractures compared to treatment with A (falls) or E (fatigue or fracture). Conclusions: The findings show a consistent trend of higher NNH (favorability) for D compared to A and E. The differences in their respective AE profiles are noteworthy not only for patients, but also for healthcare systems considering the overall risk-benefit amongst these three ARIs. Comparing D, A, and E directly in a single study may further inform their comparative profiles.[Table: see text]
EpiPen STAT: A quality improvement project for anaphylaxis management.
Authors: Aya Sato-DiLorenzo, Brendan Sendrowski, Lora Vasquez, Rena Lithotomos, Katarina Olezkiewicz, Meghan Shea
Journal: Journal of Clinical Oncology (2022)

319 Background: The medical oncology infusion unit at Beth Israel Deaconess Medical Center (BIDMC) experienced six anaphylactic reactions to chemotherapy between June 2000 and April 2021. EpiPen was delayed in all cases. In one instance, a patient experienced an emergency where she could not breathe, and her blood pressure continued to decrease. The covering nurse hesitated before administering an EpiPen. In follow-up, nurses reported a lack of confidence in administering an EpiPen. No licensed independent provider (LIP) was stationed in the infusion unit to guide nurses. The project's goal was to facilitate timely EpiPen administration, guided by the Translating Evidence into Practice (TRIP) framework. Methods: The project lead and the medical director revised the hospital’s chemotherapy reaction guidelines to highlight anaphylaxis management. They established an interdisciplinary project team with medical, nursing, pharmacy, and informatics representatives. Interventions, which started in November 2021, included a reaction management algorithm and PRN-reaction orders allowing nurses to initiate interventions while waiting for a LIP arrival. The unit educator provided EpiPen training, and the pharmacy leaders created an adverse drug reactions (ADR) kit—a locked box with necessary medications that followed BIDMC’s institutional algorithm to manage infusion reactions. Results: The project team collected post-intervention data between December 2021 and April 2022. Nurses reported twenty mild-to-severe chemotherapy reactions, including four anaphylactic episodes. Nineteen patients were discharged home on the day of reactions, and one patient required hospital admission for persistent symptoms. The management algorithm was followed in ten reactions (50%). Deviations from the algorithm were noted in eight cases, with the most frequent reason being smaller doses of antihistamine or corticosteroid. The algorithm was not applicable in two cases with atypical patient symptoms. In seventeen of the twenty reactions (85%), PRN-reaction orders were available in the electronic ordering system. The ADR kit was used in all reactions. In two of the four anaphylactic reactions, EpiPen was administered immediately following hypotension or hypoxia. In the remaining two cases, it was administered for persistent symptoms. Conclusions: The project facilitated EpiPen administration. The critical steps were systemic analysis of barriers, problem-solving with the TRIP framework, and engagement of frontline nurses. In our next step, we will consider narrowing the scope to managing acute hypotension or hypoxia. The narrower scope will enable targeted education about emergency management, potentially at the hospital’s simulation center. To ensure every patient has an order, the department could consider a standing EpiPen order for hemodynamically unstable patients.
Multi-level determinants of endometrial cancer diagnosis as experienced by Black women.
Authors: Sarah S Asad, Wendy R. Brewster, Erin E. Kent, Youngjee Choi, Lisa Spees, Sarah A Birken
Journal: Journal of Clinical Oncology (2022)

107 Background: Black women experience inequity in access to timely endometrial cancer (EC) diagnosis compared to non-Hispanic white women. Delays in obtaining a timely diagnosis and referral for treatment can amplify poorer outcomes in Black women. Communication between Black patients and providers are likely influenced by determinants at multiple levels (e.g., individual, community, systems). Examining determinants at multiple levels can provide insight on how they influence guideline-concordant EC diagnosis in Black women through patient-provider communication. This study reports on Black women’s EC diagnosis experience, from the time of symptom onset to obtaining a diagnosis. Methods: We conducted a qualitative study using semi-structured interviews guided by the socio-cultural framework for the study of health service disparities (SCF-HSD). We used deductive thematic analysis using codes from the SCF-HSD framework, and inductive thematic analysis for new themes arising in the data. Participants were recruited using a study posting on an online patient research platform associated with an academic hospital in North Carolina. Eligible patients had to identify as Black, English-speaking, aged 40 years or older, and have a diagnosis of EC within the last 3 years. Results: Thirteen Black women with EC participated in online &amp; phone interviews ranging from 22-50 minutes. Participants were primarily between 40-49 years of age (mean age = 45), stage II (100%), and either had private (47%), Medicare (23%) or Medicaid (30%) health insurance. Participants identified determinants at 3 levels: individual (symptom misinformation; delay in seeking support for symptoms - competing needs with work and family; fear and anxiety while waiting for tests and results), community (convenience of primary care clinics; existing relationships with providers; delay in referral by primary care providers; lack of information on testing rationale and expectations), and environment (distance to cancer centers; difficulty in obtaining appointments). Many participants reported that the onus was on them to find a cancer center and oncologist to conduct further diagnostic testing after seeing a primary care provider for their symptoms. When asked whether participants felt they were treated differently (positively/negatively) because of their race, many participants mentioned being Black negatively affected their ability to obtain timely appointments for diagnostic testing (e.g. biopsy, vaginal ultrasound). A few participants specifically mentioned reaching out to Black providers for management of their cancer. Conclusions: Black women with EC report several determinants to timely diagnosis at multiple levels. These findings will be mapped onto implementation strategies in a system-strengthening intervention to improve guideline-concordant diagnosis.
Retirement behavior of cancer survivors and the role of employer-sponsored health insurance.
Authors: Cathy J Bradley, Kelsey Owsley
Journal: Journal of Clinical Oncology (2022)

222 Background: Workers who rely on employment for health insurance may choose to continue working following a serious health condition, potentially harming their health in retirement. In this study, we examine the influence of retiree and employment-contingent insurance on retirement behavior and health of workers diagnosed with cancer. Methods: This longitudinal cohort study used 2000-2018 Health and Retirement Study data to examine changes in employment, weekly hours worked, and health status measures following a cancer diagnosis by health insurance status. We selected respondents who reported a new cancer diagnosis (n = 354) and a matched, non-cancer sample (n = 1,770 respondents), restricting both samples to those employed and younger than age 63. Results: Women with cancer and retiree health insurance were 21.0 percentage points less likely to work (95% CI: –38.5 to –3.5; p &lt; 0.05) relative to women with employer health insurance, but no retiree insurance. Employed women with cancer but no health insurance increased weekly hours worked by 32% relative to similar non-cancer controls. Men and women with a new cancer diagnosis and without health insurance were also less likely to work (p &lt; 0.05). Respondents with employer-based health insurance reported better subsequent health status than respondents without health insurance from their employer. Conclusions: Cancer survivors with both employer insurance and retiree health insurance are able to leave the workforce earlier, and report better health status when they stop working following a cancer diagnosis.
Uptake of second-line anticancer therapy after first-line pembrolizumab in patients with stage IV non–small cell lung cancer with PD-L1 &gt; 50%: Comparison between clinical trials and the real world.
Authors: Rebekah Rittberg, Lauren Jones, Bonnie Leung, Aria Shokoohi, D N Ionescu, Alexandra Pender, Ren Yuan, Selina K. Wong, Zamzam Salam Al-Hashami, Ying Wang, Cheryl Ho
Journal: Journal of Clinical Oncology (2022)

126 Background: In KEYNOTE-024 single agent pembrolizumab was compared to platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC) with PDL1 &gt;50%. Patients treated with pembrolizumab had an improved progression free survival and overall survival (OS). In KEYNOTE-024, 53% of patients treated with pembrolizumab received second line anticancer therapy with a median OS of 26.3 months. The objective of this study is to characterize real-world NSCLC patients who received second line therapy after pembrolizumab. Methods: A retrospective study of stage IV NSCLC patients with PDL1 &gt;50% referred to BC Cancer between 2018-2021 treated with first line pembrolizumab. Patient demographics, treatment received, and outcomes were collected retrospectively. Baseline characteristics were compared using descriptive statistics. Univariate and multivariate analysis was completed. Kaplan-Meier curves was used to calculate OS and compared using the log rank test. Results: Between 2018-2021, 718 Stage IV NSCLC patients received at least 1 cycle of pembrolizumab. Median duration on treatment was 4.4 months and follow up duration was 16.0 months. 567 (80%) had disease progression of which only 21% (n = 119) received second line systemic therapy. Within the subset with disease progression, median duration on treatment was 3.0 months and follow up duration was 11.7 months. Patients who received second line therapy were younger (p &lt; 0.001), better baseline ECOG PS (p &lt; 0.001) and had longer duration on first line pembrolizumab (p &lt; 0.001). There was no difference in sex (p = 0.519), smoking status (p = 0.416) or histology (p = 0.136). In the multivariate model including age (OR 0.95), baseline ECOG PS (PS 0-1, OR 2.59) and duration on pembrolizumab (OR 1.05) each independently impacted receipt of second line therapy, Table. Median OS from date of diagnosis was 9.6 (IQR 8.4-10.9) months in patients who did not receive additional therapy after progression and 25.3 (IQR 22.5-28.1) months in patients who received subsequent therapy, (p &lt; 0.001). Conclusions: In our stage IV NSCLC population, we found that only 21% of patients received second line systemic therapy despite it being associated with improved OS. Compared to KEYNOTE-024, this real-world population found that 60% less patients received second line systemic therapy. Although differences exist between a clinical and non-clinical trial population, these findings suggest significantly undertreating our stage IV NSCLC patients requiring increased rates of offering second line therapy.[Table: see text]
Discordance in management of adverse events associated with oral therapies in hormone receptor–positive breast cancer among health care providers and experts: Findings from an online decision support tool.
Authors: Kristen M. Rosenthal, Kelly G Brandt, Laura Spring, Marissa Marti-Smith, Timothy A. Quill, Joyce O'Shaughnessy
Journal: Journal of Clinical Oncology (2022)

382 Background: Oral targeted therapies (OTTs) inhibiting CDK4/6, PI3K, and mTOR have established roles across multiple lines of therapy in patients with advanced hormone receptor–positive, HER2-negative breast cancer (HR+ BC). Abemaciclib, a CDK4/6 inhibitor (i), now also is approved in the adjuvant setting for eligible patients with early-stage HR+ BC. These OTTs are associated with various adverse events (AEs), such as cytopenias, diarrhea, hepatotoxicity, and rash. Optimal AE management is critical to promote patient adherence and achieve the best possible outcomes. Here we report an analysis of healthcare professional (HCP) management of AEs associated with OTTs in HR+ BC using an online decision support tool. Methods: The online tool was developed with 5 BC experts providing recommendations on the management of AEs associated with OTTs. Within the online tool, HCPs were prompted to input relevant patient case details through a series of predefined questions, including which OTT and type of AE the patient is experiencing, along with their management approach. Participants were then shown an expert recommendation based on the specific characteristics of that case and were asked if their management plan changed based on that recommendation. Results: Between September 2021 and April 2022, 557 cases were entered by 390 participants. Among 291 cases of patients currently receiving oral therapy, CDK4/6i therapy was most commonly selected (82%), followed by PI3Ki (11%) and mTORi (8%) therapy. The most common AE reported for CDK4/6i, PI3Ki, and mTORi therapy were cytopenias (56%), hyperglycemia (64%), and stomatitis (57%), respectively. With CDK4/6i, HCPs were discordant with expert recommendations for management of AEs reported in 44%, 39%, and 35% of entered cases with ribociclib, abemaciclib, and palbociclib, respectively. The greatest variance between HCP and expert recommendations were with management of VTE, hepatotoxicity, QT prolongation, and rash (Table). Among HCPs with discordant results from the experts, 50% changed their AE management plan after viewing the expert recommendation. Conclusions: These data suggest that HCPs may be challenged to optimally manage AEs related to OTTs in patients with HR+ BC. Use of an online tool may enhance HCP management of these AEs for patients with HR+ BC. A detailed analysis of the tool, including HCP planned management vs expert recommendations, will be presented.[Table: see text]
Academic and community physician perspectives on breast cancer biomarker use in clinical trials.
Authors: Halle H. Thannickal, Noon Eltoum, Courtney J. Andrews, Rachel Marie Frazier, Lynne I. Wagner, Lauren P. Wallner, Antonio C. Wolff, Gabrielle Betty Rocque
Journal: Journal of Clinical Oncology (2022)

349 Background: Biomarkers are regularly utilized to select treatment within cancer clinical trials. However, there remains a lack of understanding regarding physician perspectives on what data is needed for physicians to comfortably use these markers to escalate or de-escalate chemotherapy. Methods: Semi-structured qualitative interviews with medical oncologists from different academic and community-based cancer centers were conducted to investigate perspectives on the utilization of biomarkers to de-escalate chemotherapy. Key topics explored included: (1) physician preference for biology-based (e.g. genomic profiles) vs. response-based (e.g. complete pathologic response) biomarkers, and (2) importance of personal familiarity with biomarkers. Interviews were audio-recorded and transcribed. Two independent coders analyzed transcripts using a constant comparative method in NVivo to identify major themes. Analysis was stratified by practice-type to elucidate differences between oncologists at academic and community practices. Results: Of the 39 participating physicians, 51% practiced in an academic setting and 49% practiced in a community setting. The majority of physicians (67% overall, 77% community, 59% academic) did not have a preference for biology-based vs. response-based biomarkers, if the data is equally strong and clinical use is appropriate for the clinical context (e.g. patient subtype). Many physicians were reassured by achieving a real-time therapeutic response, with 23% of physicians preferring response-based biomarkers. One physician stated, “I am still more comfortable with a real-time, well-validated biomarker, response marker, than I am with an overall predictive marker for a population”. In contrast, 10% (all academic) preferred biology-based biomarkers. One physician commented “I think the biology is probably more attractive because that potentially allows you to avoid treatment, whereas pathCR they've already had to get treatment to get there”. The majority of academic physicians (55%) felt that strong data was more important than personal familiarity with regards to implementation of novel biomarkers, as noted by one who stated, “As long as there's good data, I don't care.” 15% of community physicians shared a similar view. The majority of community physicians (54%) voiced familiarity to be more important in their comfort with biomarker use as noted by one physician who stated, “I think things I’m already familiar with, I'm more inclined to feel good about”. 18% of academic physicians held a similar perspective. Conclusions: Academic and community physicians’ perspectives regarding use of novel biomarkers overlap, with multiple factors playing a role in how these biomarkers are used in decision-making. Future research is needed to understand the impact of biomarker selection on clinical trial enrollment.
Adaptation of a financial toxicity intervention for scale-up to diverse contexts: Core functions of Lessening the Impact of Financial Toxicity (LIFT).
Authors: Sarah A Birken, Stephanie B. Wheeler, Cheyenne Wagi, Michelle L. Manning, Carla Strom, Ronny A. Bell, Mindy Gellin, Neda Padilla, Cindy Rogers, Julia Rodriguez-O'Donnell, Donald L. Rosenstein
Journal: Journal of Clinical Oncology (2022)

345 Background: Rural and non-English speaking populations experience a disproportionate burden of financial toxicity and access to services for their cancer care. Lessening the Impact of Financial Toxicity (LIFT) is an intervention designed to address financial toxicity (FT) through financial navigation (FN). FN identifies patients at risk for FT, assesses eligibility for financial support, clarifies costs, and develops strategies to cope with costs. LIFT was successful in reducing financial toxicity in preliminary studies among English-speaking patients with high levels of FT in a single large academic cancer center. To benefit diverse patients with FT in cancer programs across the US, there is a need to adapt LIFT. Adapting LIFT requires distinguishing between its core functions— the components of LIFT key to its effectiveness and implementation, and its forms— the activities that comprise LIFT, facilitate its implementation, and may be adapted to accommodate new populations and contexts. We completed the first stage of adaptation, identifying LIFT core functions. Methods: We conducted interviews with individuals responsible for LIFT’s design and implementation. Interview questions were based on Kirk’s methods for identifying core functions and were recorded and transcribed verbatim. Using a codebook based on the Model for Adaptation Design and Impact, we coded interview transcripts and identified themes related to how LIFT engaged cancer program staff in FN (implementation core functions) and decreased FT (intervention core functions). Results: Eight interview participants filled various roles in designing and implementing LIFT (e.g., P.I.s; FNs). LIFT intervention core functions include a systematic way of cataloging knowledge, resources, and tracking patient information; using patient-specific needs to guide access to resources; ongoing, dynamic assistance and strong one-on-one relationships between navigators and patients; and removing common barriers to accessing resources. Conclusions: We identified core functions key to LIFT’s effectiveness and implementation. Next steps include identifying systematic differences between LIFT’s original context and population and new ones. Successfully adapting LIFT has the potential to extend its benefits to diverse patients in cancer programs throughout the US, such as Spanish-speaking patients served by rural community cancer programs.